Recall Z-2119-2010 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
X-Celerate Instrumentation Punch Thru Tibial Base Plate, Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007, 3750-0009, 3750-0011, 3750-0013; Stryker Howmedica Osteonics Corp Scorpio Total Knee System
| Date | Aug 2, 2010 (initiated Apr 5, 2010) |
| Status | Terminated |
| Reason | The locating pins on the Punch Thru Tibial Baseplates could break or disassociate from the main body of the instrument. |
| Root cause | Device Design |
| Action | Stryker Urgent Device Correction letters dated April 5, 2010, were sent to all Stryker branches/agencies, hospital Risk Management and surgeons who have used the product by Federal Express. Questions on the bulletin should be directed to Scott Solis, Product Manager ,Knee Marketing at 201-831-5665. |
| Quantity | 8276 |
| Distribution | Worldwide distribution: USA, China, Taiwan, India, Australia, Korea, Singapore, Germany, France, Spain, Italy, Switzerland, Poland, Romania, South Africa, United Kingdom, Netherlands, Sweden, Turkey, Japan, Chile, Brazil, Colombia, Mexico, Panama, Argentina, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.